Oncology Research Articles

"Let him die. He caused it": A qualitative study on cancer stigma in Tanzania.

Cancer stigma presents a critical barrier to care seeking, contributing to delayed presentation and poor cancer outcomes worldwide. The burden of cancer in Tanzania is on the rise, with cancer being the third-leading cause of death in the country. Despite rising incidence and poor outcomes of cancer, cancer-related stigma interventions have received low prioritization. There is a need for sound research that focuses on understanding attitudes driving stigma, its impact on care-seeking and treatment adherence, and intervention models to reduce stigma. We used a cross-sectional qualitative study design. We administered three open-ended qualitative questions to 140 adults newly diagnosed with cancer in Moshi, Tanzania. The questions explored common attitudes toward people with cancer, the perceived impact of cancer-related stigma on care engagement, and ideas for reducing cancer stigma. Patients were recruited during routine appointments at the Cancer Center at Kilimanjaro Christian Medical Center. Data were analyzed using a team-based, applied thematic approach and NVivo 12 software. All participants described stigma as a significant challenge for treatment and receiving support from their social networks. Perceptions of financial burden, misconceptions about cancer, such as the belief that it is contagious, and fear of death, were common attitudes driving cancer stigma. Most participants feared that symptoms would prevent them from being able to work and that the cost of cancer care would drive away loved ones. Stigma was not a ubiquitous response, as some participants reported increased care and social support from family members after a cancer diagnosis. Experiences of stigma contributed to feelings of shame, fear of burdening the family, reduced resources to access treatment, and disengagement from care. Common substitutes to medical therapies included religious interventions and traditional medicine, perceived as less expensive and less stigmatizing. Many participants felt they would benefit from improved financial support, professional counseling, and education for families and communities to reduce stigmatizing attitudes and enhance social support. There is a need for intervention studies focused on improving cancer literacy, community advocacy to reduce cancer stigma, and increasing emotional and practical support for people with cancer and their families. There is also a clear need for policy efforts to make cancer care more affordable and accessible to reduce the financial burden on patients and families.

Improving Distress Screening for People with Prostate Cancer: Evaluation of an E-Learning Course to Increase Healthcare Professionals’ Knowledge

ObjectivesPsychological distress can occur following diagnosis and treatment for prostate cancer, compromising psychosocial wellbeing. Improved recognition and management of distress by healthcare professionals can enhance clinical practice and promote evidence-based prostate cancer care. This paper explores the effectiveness and feasibility of the online Distress Screening for Prostate Cancer course, designed to improve healthcare professionals’ understanding of screening for prostate cancer-related distress. It aims to evaluate whether this e-learning course increases learners’ knowledge of distress screening for prostate cancer. MethodsHealthcare professionals were invited to enroll in the online course and complete optional evaluation questions. The pretest posttest design identified changes in learners’ knowledge about distress screening for people with prostate cancer, including prevalence, risk factors, assessment and management strategies for distress (n = 149). Learners also rated satisfaction in a cross-sectional survey (n = 116). Most respondents were nurses, including Prostate Cancer Specialist Nurses. ResultsLearners’ knowledge of distress screening was higher after course completion. Improvement between pre- and posttest results was statistically significant for four of ten items, including risk of prostate cancer-related distress, and suicidality, and the purpose of distress screening. Learners reported high satisfaction with course content, structure, engagement, relevance, and approach. They particularly valued the narrative-based approach and interactivity. Small numbers encountered technological problems and some offered suggestions to improve learner feedback. ConclusionsThe course improved healthcare professionals’ knowledge of distress among people affected by prostate cancer. Learners found the e-learning format feasible and acceptable. Implications for Nursing PracticeDeeper understanding of the psychological implications of diagnosis and treatment of prostate cancer can help healthcare professionals respond to and manage distress among men and their families, and provide supportive care to improve health-related quality of life. Access to an online course can offer effective, feasible education on distress screening.

Representativeness of Patients With Lung Cancer in an Integrated Health Care Delivery System.

Observational research is important for understanding the real-world benefits of advancements in lung cancer care. Integrated health care systems, such as Kaiser Permanente Northern California, have extensive electronic health records suitable for such research, but the generalizability of their populations is often questioned. Leveraging data from the California Cancer Registry, the authors compared distributions of demographic and clinical characteristics, in addition to neighborhood and environmental conditions, between patients diagnosed with lung cancer from 2015 through 2019 at Kaiser Permanente Northern California, National Cancer Institute-designated cancer centers (NCICCs), and all other non-NCICC hospitals within the same catchment area. Of 20,178 included patients, 30% were from Kaiser Permanente Northern California, 8% from NCICCs, and 62% from other non-NCICC hospitals. Compared to NCICC patients, Kaiser Permanente Northern California patients were more similar to other non-NCICC patients on most characteristics. Compared to other non-NCICC patients, Kaiser Permanente Northern California patients were slightly older, more likely to be female, and less likely to be Hispanic or Asian/Pacific Islander and to reside in lower socioeconomic status (SES) neighborhoods. In contrast, NCICC patients were younger, less likely to be female or from non-Asian/Pacific Islander minoritized racial groups, and more likely to present with early-stage disease and adenocarcinoma and to reside in neighborhoods with higher SES and lower air pollution than Kaiser Permanente Northern California or other non-NCICC patients. Patients from Kaiser Permanente Northern California, compared to NCICCs, are more broadly representative of the underlying patient population with lung cancer. Research using electronic health record data from integrated health care systems can contribute generalizable real-world evidence to benchmark and improve lung cancer care.

Insurance Denials and Patient Treatment in a Large Academic Radiation Oncology Center

Insurance barriers to cancer care can cause significant patient and clinician burden. To investigate the association of insurance denial with changes in technique, dose, and time to delivery of radiation oncology treatment. In this single-institution cohort analysis, data were collected from patients with payer-denied authorization for radiation therapy (RT) from November 1, 2021, to December 8, 2022. Data were analyzed from December 15, 2022, to December 31, 2023. Insurance denial for RT. Association of these denials with changes in RT technique, dose, and time to treatment delivery was assessed using χ2 tests. A total of 206 cases (118 women [57.3%]; median age, 58 [range, 26-91] years) were identified. Most insurers (199 [96.6%]) were commercial payers, while 7 (3.4%) were Medicare or Medicare Advantage. One hundred sixty-one patients (78.2%) were younger than 65 years. Of 206 cases, 127 (61.7%) were ultimately authorized without any change to the requested RT technique or prescription dose; 56 (27.2%) were authorized after modification to RT technique and/or prescription dose required by the payer. Of 21 cases with required prescription dose change, the median decrease in dose was 24.0 (range, 2.3-51.0) Gy. Of 202 cases (98.1%) with RT delivered, 72 (34.9%) were delayed for a mean (SD) of 7.8 (9.1) days and median of 5 (range, 1-49) days. Four cases (1.9%) ultimately did not receive any authorization, with 3 (1.5%) not undergoing RT, and 1 (0.5%) seeking treatment at another institution. In this cohort study of patients with payer-denied cases, most insurance denials in radiation oncology were ultimately approved on appeal; however, RT technique and/or effectiveness may be compromised by payer-mandated changes. Further investigation and action to recognize the time and financial burdens on clinicians and clinical effects on patients caused by insurance denials of RT is needed.

Oncology nurses' practices on diagnosis, prevention, and management of delirium

Objective: To determine oncology nurses’ practices about the diagnosis, prevention, and management of delirium. Background: Delirium can occur at any stage of the disease process of patients with cancer, or it can develop when the first diagnosis is learned. Study Design and Methods: A cross-sectional design was used. The study was conducted between May 10 and July 16, 2021 in Turkey with 181 nurses who worked in the oncology units of public and private hospitals and were reached by using the snowball sampling method. Data were statically analysed. Results: Of the nurses, 48.6% have a bachelor's degree and the average working years in oncology is 6.61+ 5.47, 38.1% had been making routine delirium assessments, and only 5.5% of these nurses had prior experience using a screening tool. Also, 38.1% of the nurses had difficulty diagnosing delirium, with the patient group they had difficulty diagnosing most often being patients with dementia, hypoactive delirium, and those who were sedated, respectively. The rate of nurses who worked with a patient with delirium in the last month was 31.5%, and 40.3% could not determine the type of delirium. While the nurses' definition of hyperactive delirium findings was high, their definition of hypoactive delirium findings such as lethargy (48.8%), decreased psychomotor activity (47.7%) and withdrawal (56.1%) was low. In the study, it was found that being male, having an undergraduate degree in nursing, having professional work experience, having a lower patient-to-nurse ratio, using a screening tool, having experience working with patients diagnosed with delirium, and having positive views on delirium treatment had a significant impact on nurses' routine follow-up of delirium (p<0.05). In addition, it was determined that those who had experience working with patients diagnosed with delirium had less difficulty diagnosing delirium (p<0.05). Also, 82.4% of the nurses stated that they first applied pharmacological treatment after the diagnosis of delirium and that they most frequently used haloperidol (35%), benzodiazepine (29.8%) and dexmedetomidine (22.8%). Although nurses were self-confident about the management of delirium, they thought that it was difficult to prevent and treat delirium in patients with cancer. Conclusions: Although approximately one-third of the nurses had cared for patients diagnosed with delirium in the last month, the rate of using a measurement tool for routine delirium screening and diagnosis was low. Implications for research, policy, and practice: It was concluded that it was important to support the education of nurses with case examples in in-service or certificate programs, workforce planning should be made according to patient/nurse ratios, and evidence-based care procedures should be prepared and implemented so that oncology nurses could do routine follow-up of delirium in patients diagnosed with cancer, use a valid and reliable screening tool, and manage effectively and appropriately delirium. What is already known about this topic? Although the incidence of delirium is high in cancer patients, it is not always diagnosed appropriately or managed effectively. Despite the factors limiting diagnosis and treatment in cancer patients, 40% of delirium cases can be prevented. Delirium is a syndrome that can be managed with pharmacological and non-pharmacological applications. What this paper adds: In the diagnosis and management of delirium, whether nurses use screening tools and do routine follow-up, the level of their education, their experience working with patients diagnosed with delirium, the number of patients they provide care for, their self-confidence, and their positive attitudes towards delirium are factors that impact on the diagnosis and outcomes. Nurses should be supported with case-based education that will increase their knowledge and skills regarding the diagnosis and management of delirium in patients diagnosed with cancer. This approach will increase nurses' experience before they encounter a patient with delirium. For effective diagnosis and management of delirium, workforce planning should consider patient/nurse ratios in oncology units as a workload management and patient safety measure. It is recommended to prepare and implement institutional care procedures for the diagnosis, management and follow-up of delirium in oncology units.

Perception of enhanced learning in medicine through integrating of virtual patients: an exploratory study on knowledge acquisition and transfer

IntroductionVirtual Patients (VPs) have been shown to improve various aspects of medical learning, however, research has scarcely delved into the specific factors that facilitate the knowledge gain and transfer of knowledge from the classroom to real-world applications. This exploratory study aims to understand the impact of integrating VPs into classroom learning on students’ perceptions of knowledge acquisition and transfer.MethodsThe study was integrated into an elective course on “Personalized Medicine in Cancer Treatment and Care,” employing a qualitative and quantitative approach. Twenty-two second-year medical undergraduates engaged in a VP session, which included role modeling, practice with various authentic cases, group discussion on feedback, and a plenary session. Student perceptions of their learning were measured through surveys and focus group interviews and analyzed using descriptive statistics and thematic analysis.ResultsQuantitative data shows that students highly valued the role modeling introduction, scoring it 4.42 out of 5, and acknowledged the practice with VPs in enhancing their subject matter understanding, with an average score of 4.0 out of 5. However, students’ reflections on peer dialogue on feedback received mixed reviews, averaging a score of 3.24 out of 5. Qualitative analysis (of focus-group interviews) unearthed the following four themes: ‘Which steps to take in clinical reasoning’, ‘Challenging their reasoning to enhance deeper understanding’, ‘Transfer of knowledge ‘, and ' Enhance Reasoning through Reflections’. Quantitative and qualitative data are cohered.ConclusionThe study demonstrates evidence for the improvement of learning by incorporating VPs with learning activities. This integration enhances students’ perceptions of knowledge acquisition and transfer, thereby potentially elevating students’ preparedness for real-world clinical settings. Key facets like expert role modeling and various authentic case exposures were valued for fostering a deeper understanding and active engagement, though with some mixed responses towards peer feedback discussions. While the preliminary findings are encouraging, the necessity for further research to refine feedback mechanisms and explore a broader spectrum of medical disciplines with larger sample sizes is underscored. This exploration lays a groundwork for future endeavors aimed at optimizing VP-based learning experiences in medical education.

Tumors, Treatments, and Trust: Cancer Characteristics, Outcomes, and Screening Uptake in Transgender and Gender-Diverse Patients.

More than 2.5 million adults in the United States identify as transgender or gender-diverse (TGD), but little data exist on cancer screening and care for this population. We examined cancer characteristics, screening adherence, genetic testing, and provider inclusive language for TGD patients with cancer. This single institution retrospective cohort study identified TGD patients with cancer between 2000 and 2022. Demographic, clinicopathological, treatment, and screening data were collected, as well as data on gender-affirming care (GAC) and use of patients' personal pronouns in medical records. Descriptive statistics and regression analyses were used to report outcomes. Sixty unique patients with 69 cancer diagnoses were included: 63.3% were transgender women, 21.7% transgender men, 6.7% nonbinary, and 8.3% were genderqueer. Sixty-five percent had a family history of cancer. Only 46.2% of thosewho met genetic testing criteria were referred. On review of recommended cancer screening, colorectal screening had the greatest uptake (62%), followed by breast (48.3%), lung (35.7%), cervical (33.3%), and prostate (32%); 8.5% of cancers were diagnosed on screening. Individuals with Medicare had reduced odds of screening uptake (OR 0.07, 95% CI 0.01-0.58) versus private insurance. With respect to GAC, 73.3% used gender-affirming hormone therapy and 41% had gender-affirming surgery. After initiating GAC and asserting personal pronouns, 75% were referred to by incorrect name/pronouns in provider documentation. Our TGD cancer patient cohort had low rates of disease-specific cancer screening and inadequate genetic referrals.Many providers did not use appropriate patient names/pronouns. Provider and patient interventions are needed to ensure inclusive preventative and oncologic care for this marginalized population.

Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?

Tyrosine kinase inhibitors (TKIs) have demonstrated significant efficacy against various types of cancers through molecular targeting mechanisms. Over the past 22 years, more than 100 TKIs have been approved for the treatment of various types of cancer indicating the significant progress achieved in this research area. Despite having significant efficacy and ability to target multiple pathways, TKIs administration is associated with challenges. There are reported inconsistencies between observed food effect and labeling administration, challenges of concomitant administration with acid-reducing agents (ARA), pill burden and dosing frequency. In this context, the objective of present review is to visit administration challenges of TKIs and effective ways to tackle them. We have gathered data of 94 TKIs approved in between 2000 and 2022 with respect to food effect, ARA impact, administration schemes (food and PPI restrictions), number of pills per day and administration frequency. Further, trend analysis has been performed to identify inconsistencies in the labeling with respect to observed food effect, molecules exhibiting ARA impact, in order to identify solutions to remove these restrictions through novel formulation approaches. Additionally, opportunities to reduce number of pills per day and dosing frequency for better patient compliance were suggested using innovative formulation interventions. Finally, utility of physiologically based pharmacokinetic modeling (PBPK) for rationale formulation development was discussed with literature reported examples. Overall, this review can act as a ready-to-use-guide for the formulation, biopharmaceutics scientists and medical oncologists to identify opportunities for innovation for TKIs.

A Prospective Questionnaire-Based Study Evaluating Genetic Literacy and Impact of Brief Educational Intervention Among Breast Cancer Patients in a Low- to Middle-Income Country.

A significant proportion of breast cancer cases are hereditary and are potentially preventable. However, adoption of the preventive measures remains a significant challenge, particularly because of to lack of knowledge and awareness in low- to middle-income countries. This prospective study conducted at a high-volume tertiary care cancer center in North India to assess the knowledge, awareness, and attitudes of female breast cancer patients and impact of a brief educational intervention. The study involved three phases: pre-interventional assessment, educational intervention, and post-interventional assessment utilizing a structured questionnaire. The study involved 300 newly diagnosed breast cancer patients; 16.7% were familial. At the outset, 87.0% patients had low knowledge of risk factors, 90.3% about screening, and 32.7% about treatment. Awareness levels were low: 13.7% aware of familial risk and 2.7% of breast cancer genes. Affordability of genetic testing was low (15.2%), and interest in testing for self and family members was limited (32.0% and 26.3%). Following educational intervention, a significant positive percentage change was noticed in knowledge (risk factors: 12.8%, screening: 36.2%, treatment: 82%), awareness (familial risk: 66.7%, BRCA gene: 12.3%), and attitude (testing for self: 17.8%, family: 19.5%). This study highlights the significant knowledge gaps among breast cancer patients regarding genetics. The educational intervention led to notable improvements in knowledge, awareness, and attitudes, underscoring the importance of tailored patient education in breast cancer care.

Factors Influencing Implementation of the Commission on Cancer’s Breast Synoptic Operative Report (Alliance A20_Pilot9)

BackgroundThe technical aspects of cancer surgery have a significant impact on patient outcomes. To monitor surgical quality, in 2020, the Commission on Cancer (CoC) revised its accreditation standards for cancer surgery and introduced the synoptic operative reports (SORs). The standardization of SORs holds promise, but successful implementation requires strategies to address key implementation barriers. This study aimed to identify the barriers and facilitators to implementing breast SOR within diverse CoC-accredited programs.MethodsIn-depth semi-structured interviews were conducted with 31 health care professionals across diverse CoC-accredited sites. The study used two comprehensive implementation frameworks to guide data collection and analysis.ResultsSuccessful SOR implementation was impeded by disrupted workflows, surgeon resistance to change, low prioritization of resources, and poor flow of information despite CoC’s positive reputation. Participants often lacked understanding of the requirements and timeline for breast SOR and were heavily influenced by prior experiences with templates and SOR champion relationships. The perceived lack of monetary benefits (to obtaining CoC accreditation) together with the significant information technology (IT) resource requirements tempered some of the enthusiasm. Additionally, resource constraints and the redirection of personnel during the COVID-19 pandemic were noted as hurdles.ConclusionsSurgeon behavior and workflow change, IT and personnel resources, and communication and networking strategies influenced SOR implementation. During early implementation and the implementation planning phase, the primary focus was on achieving buy-in and initiating successful roll-out rather than effective use or sustainment. These findings have implications for enhancing standardization of surgical cancer care and guidance of future strategies to optimize implementation of CoC accreditation standards.

Personalized cancer T-cell therapy takes the stage, mirroring vaccine success.

Personalized T-cell therapy is emerging as a pivotal treatment of cancer care by tailoring cellular therapies to individual genetic and antigenic profiles, echoing the exciting success of personalized vaccines. We describe here the parallel evolution and analogies of cancer vaccines and T-cell therapies.

Changes in body composition in early breast cancer patients treated with aromatase inhibitors

PurposeThe aim of the study was to analyze the modification of total and regional body composition in early breast cancer patients treated with aromatase inhibitors (AIs).MethodsThis is a prospective, single-center, observational, longitudinal study. Four-hundred and twenty-eight patients treated with adjuvant aromatase inhibitors were enrolled at the Medical Oncology and Breast Unit of Spedali Civili Hospital in Brescia from September 2014 to June 2022. Several body composition parameters including total and regional fat and lean body mass were investigated with dual-energy X-ray absorptiometry (DXA) scan at baseline and after 18 months of treatment with aromatase inhibitors.ResultsA significant increase in fat body mass (mean + 7.2%, 95% confidence interval [CI]: 5.5;8.9%) and a reduction in lean body mass (mean −3.1%, 95% CI −3.9; −2.4) were documented in this population. The changes in fat and lean body mass varied considerably according to different body districts ranging between + 3.2% to + 10.9% and from−1.3% to −3.9%, respectively.ConclusionAromatase inhibitor adjuvant therapy in early breast cancer is associated with changes in body composition, with a wide variability among different body districts, leading to a risk of sarcopenic obesity. Supervised physical exercise that focuses on single body parts that may display detrimental variations may be beneficial for AIs treated patients.

Advancing Equity in Cancer Care: The Critical Role of Sexual Orientation and Gender Identity Data Collection.

New study highlights critical gaps and opportunities to enhance equitable cancer care for sexual and gender minority patients.

IMpower010: Final disease-free survival (DFS) and second overall survival (OS) interim results after ≥5 years of follow up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer (NSCLC).

LBA8035 Background: IMpower010 (NCT02486718) met its primary endpoint of significant DFS improvement with atezo vs BSC after adj chemotherapy in resected NSCLC in the PD-L1 TC ≥1% and all-randomized stage II-IIIA populations, leading to worldwide approval of adj atezo for PD-L1 TC ≥1% or PD-L1 TC ≥50% stage II-IIIA NSCLC. At OS IA1, a trend favoring atezo was seen in the PD-L1 TC ≥1% stage II-IIIA population. Here we report findings from the DFS FA and OS IA2. Methods: The IMpower010 study design has been previously described (Felip et al, Lancet 2021). The primary DFS and secondary OS endpoints were tested hierarchically: DFS in the PD-L1 TC ≥1% (SP263) stage II-IIIA, then in the all-randomized stage II-IIIA, and then in the intent-to-treat (ITT; stage IB-IIIA) populations, followed by OS in the ITT population. Secondary endpoints included 3- and 5-y DFS and DFS in the PD-L1 TC ≥50% (SP263) stage II-IIIA population. OS in the ITT population could only be formally tested if the significance boundary for DFS in that population was crossed. Results: At the DFS FA and OS IA2 (clinical cutoff date: Jan 26, 2024), with a minimum follow-up of 60 mo, DFS and OS for the PD-L1 TC ≥1% and TC ≥50% stage II-IIIA populations were consistent with previously observed benefit; the difference in median (m) DFS between arms in the PD-L1 TC ≥1% population was 31.2 mo (Table). In the ITT population, the significance boundary for DFS was not crossed and OS was similar between arms, although data were immature. The safety profile of atezo was consistent with prior analyses. Conclusions: These results provide the first cancer immunotherapy data with ≥5 y of follow-up from a Phase III study in resectable NSCLC. Although the statistical boundary for the ITT population was not crossed, DFS benefit with adj atezo continues to translate into a positive OS trend vs BSC in the PD-L1 TC ≥1% and TC ≥50% stage II-IIIA populations. These results further support the use of adj atezo in PD-L1–selected populations. Clinical trial information: NCT02486718 . [Table: see text]

Optimizing perioperative treatment for potentially resectable stage III squamous cell lung carcinoma: promising results of a condensed four-cycle regimen with tislelizumaband chemotherapy

BackgroundThe standard care for resectable non-small cell lung cancer (NSCLC) involves perioperative therapy combining chemotherapy and immune checkpoint inhibitors, typically lasting 6 to 12 months. However, the optimal treatment strategies for potentially resectable squamous cell lung carcinoma (SCC) remain unclear. This Phase 2 trial aimed to assess the efficacy and safety of a condensed four-cycle perioperative treatment regimen with tislelizumab combined with chemotherapy in patients with potentially resectable stage III SCC.MethodsPatients with potentially resectable stage IIIA-IIIB (N2) SCC received intravenous tislelizumab, albumin-bound paclitaxel, and carboplatin for up to four cycles. The primary endpoints were major pathologic response (MPR) and incidence of treatment-related adverse events. Safety and potential biomarkers for efficacy prediction were also assessed.ResultsAmong 35 enrolled patients, 32 underwent surgery with R0 resection achieved in all cases. MPR was achieved in 24 patients and pathological complete response (pCR) in 14 patients. Radiographic objective response was observed in 31 patients. The 12-month and 24-month event-free survival rate was 85.7 and 61.0%, respectively. Four patients experienced grade 3 or 4 adverse events. Tumor tissue based next-generation sequencing revealed the potential associations between several biomarkers and pathological response, including tumor neoantigen burden score, 18-gene expression profile score, CD8 + T cells, M1/M2 macrophages ratio and interferon‐gamma expression level. Besides, circulating tumor DNA (ctDNA) dynamics and concentration were also associated with pathological response and the presence of ctDNA at postoperative month 1 was a strong predictor for disease relapse. Furthermore, metagenomic sequencing in bronchoalveolar lavage fluid demonstrated Streptococcus was the most abundant genus in the pCR group.ConclusionsA condensed four-cycle perioperative treatment regimen of tislelizumab combined with chemotherapy demonstrated promising efficacy and manageable toxicities in potentially resectable stage III SCC. Specific biomarkers showed potential for predicting treatment efficacy and the mechanism of superior antitumor response of pCR patients was preliminarily and indirectly explored.Trial registrationClinicalTrials.gov, NCT05024266. Registered August 27, 2021.

Randomized double-blind placebo-controlled trial evaluating pregabalin for chronic cough in patients with lung cancer.

LBA12082 Background: Chronic cough is a distressing symptom that detracts from the quality of life (QoL) of patients with cancer. Developing effective therapies for cough is an unmet need, with no approved medicines available. Neuromodulators like pregabalin may act centrally as cough suppressants. Methods: Randomized double-blind placebo-controlled study in the Department of Medical Oncology at Tata Memorial Hospital (Mumbai, India) in patients with locally advanced/metastatic non-small-cell lung cancer (NSCLC) with at least 2 weeks history of moderate or severe cough. Patients had ECOG PS 0-2, and creatinine clearance > 60 mL/min. Randomization was 1:1 to pregabalin 300 mg orally daily or matching placebo, both administered for 9 weeks. Primary endpoint was the difference in cough severity as measured by Visual Analog Scale (VAS) after 9 weeks treatment with pregabalin versus placebo. Secondary endpoints included cough severity on day 7 and week 9 measured by VAS, and Manchester Cough in Lung Cancer Scale (MCLCS); side-effects, and QoL assessed by EORTC QLQ C30 and LC13. Means of the change from baseline scores were calculated for patients in each arm, and compared between two arms by independent samples Mann Whitney U test. P < 0.05 was considered significant. Results: Between Jul 2022 and Dec 2023, we enrolled 166 patients: 83 to each arm. Median age was 56 years (IQR, 47-62.5); 112 (67.5%) were male, and 149 (89.8%) had metastatic NSCLC. Baseline cough severity was grade 2 in 127 (76.5%) and grade 3 in 37 (22.6%); median cough duration was 163 days. The therapy (pregabalin/placebo) was well tolerated in both arms, with no difference in grade > 3 toxicities between the two arms; P=0.908. Systemic cancer-directed therapy was started in 95.2% and 91.4% of patients in the pregabalin and placebo arms, respectively; P=0.328. By week 9, subjective improvement in cough was reported by 45 (57%) patients in pregabalin arm, and 40 (52.6%) patients in placebo arm; P=0.846. The mean VAS score (in mm) decreased from 71.58 at baseline, to 45.32 at day 7, and 19.73 by week 9 in the pregabalin arm; corresponding values in the placebo arm were 71.74, 46.23, and 21.18, respectively; P=0.530. Cough assessment by mean MCLCS scores showed a similar decrease throughout the course of the study, with no statistically significant differences between the two arms (Pregabalin-Baseline: 27.63, Day 7: 23.49, Week 9: 17.39; Placebo-Baseline: 27.28, Day 7: 23, Week 9: 17.34); P=0.455. There was no significant difference in QoL between the two arms. Mean LCCO (cough symptom question on QLQ LC13) score decreased from 75.9 (baseline) to 54.2 (day 7) to 36.4 (week 9) in pregabalin arm, vs 66.3, 54, and 31.4, respectively, in placebo arm; P=0.150. Conclusions: Pregabalin does not lead to a significant decrease in cough in patients with lung cancer. Systemic cancer-directed therapy is the most effective antitussive therapy for cancer-induced cough. Clinical trial information: CTRI/2020/11/029275 .

Primary outcomes of the enhanced, EHR-facilitated cancer symptom control (E2C2) cluster-randomized, stepped wedge, pragmatic trial.

LBA12006 Background: Symptom burden and functional decline are prevalent, inconsistently treated, and associated with adverse health outcomes in patients with cancer. Symptom monitoring with electronic patient-reported outcome measures (ePROMs) has yielded mixed results due, in part, to care teams’ variable bandwidth and resourcing for symptom management. The collaborative care model (CCM) offers a validated means to address these issues and potentially improve clinical and health services outcomes. Capturing ePROMS through the electronic health record (EHR) for use in CCM delivery provides a potentially scalable approach to manage symptoms at the population level. Methods: E2C2 is a cluster-randomized, population-level, stepped wedge pragmatic trial that compares a bundled, EHR-facilitated, CCM-based intervention to improve control of SPPADE symptoms (Sleep interference, Pain, impaired Physical function, Anxiety, Depression, and Energy deficit/fatigue) with usual care. All patients, regardless of cancer type or stage, treated in the medical oncology clinics of a multi-state health system, were assigned to one of fifteen clusters. Control and intervention conditions monitored SPPADE symptoms with Epic EHR administered 11-point numerical rating scales (NRSs). Moderate and severe symptoms were defined as 4-6/10 and >7/10, respectively. The intervention added EHR clinician decision support; automated delivery of symptom self-management information; and options to address severe symptoms with a dedicated symptom care manager. The primary outcome was post-baseline SPPADE scores assessed using multivariate regression of six cluster-period mean SPPADE symptom scores against E2C2 exposure, fixed cluster and secular time effects. Results: From March 2019 to January 2023, 50,559 patients were assigned to E2C2 clusters and 40,295 completed at least one ePROM. At first assessment, participants’ mean age was 63.3 years; 58% were female; 26% were rural, and the prevalences of moderate or worse symptoms were fatigue 42%, impaired function 34%, sleep disturbance 34%, anxiety 27%, pain 26%, and depression 23%. The intervention significantly reduced mean composite SPPADE symptom scores, p <0.001, among all patients, as well as those with >1 moderate or worse symptom. All mean symptom scores were lower in the intervention group, with the largest effects detected among patients with fatigue -0.2 (-0.4, -0.07), anxiety -0.14 (-0.2, -0.03), and depression -0.1 (-0.2, -0.002). Conclusions: In this large cluster-randomized trial, an EHR-facilitated, bundled intervention that scaled CCM-based surveillance and management of SPPADE symptoms significantly reduced population-level symptom burden, particularly for fatigue, anxiety, and depression. This study provides real world evidence and the foundation for future national efforts aimed at controlling symptoms in patients with cancer. Clinical trial information: NCT03892967 .

Recent Advancements and Innovations in Pediatric Precision Oncology.

Precision oncology incorporates comprehensive genomic profiling into the individualized clinical care of pediatric cancer patients. In recent years, comprehensive pan-cancer analyses have led to the successful implementation of genomics-based pediatric trials and accelerated approval of novel targeted agents. In addition, disease-specific studies have resulted in molecular subclassification of myriad cancer types with subsequent tailoring of treatment intensity based on the patient's prognostic factors. This review discusses the progress of the field and highlights developments that are leading to more personalized cancer care and improved patient outcomes. Increased understanding of the evolution of precision oncology over recent decades emphasizes the tremendous impact of improved genomic applications. New technologies and improved diagnostic modalities offer further promise for future advancements within the field.

Abstract B014: Unveiling the future: Exploring cutting-edge technologies for synthetic lethality discovery

Abstract Synthetic lethality discovery is an emerging field of research that aims to reshape the landscape of cancer treatment, offering new hope and possibilities for patients faced with challenging diagnoses. In this article, we explored the cutting-edge technologies shaping the future of synthetic lathality research. Artificial intelligence and machine learning are not just buzzwords but indispensable tools that are shaping the field of precision medicine and personalized cancer treatment. By leveraging the power of computational tools, scientists can accelerate the identification of synthetic lethal interactions and pave the way for the development of more effective targeted cancer therapies. Through case studies, researchers can uncover the functional genomics of complex diseases and identify novel drug targets for cancer therapy. The integration of multi-omics approaches not only enhances the depth of analysis but also offers a more nuanced understanding of the molecular mechanisms driving synthetic lethal interactions, paving the way to unlock novel therapeutics and personalized treatment strategies. In addition, the integration of high-throughput screening techniques, such as CRISPR-Cas9 gene editing, opens up new avenues for identifying new drug targets and therapeutic strategies, ultimately paving a new era where personalized and targeted therapies redefine the way we approach cancer care, ushering in a novel era of precision and efficacy in medicine. Citation Format: Peter Oloche David. Unveiling the future: Exploring cutting-edge technologies for synthetic lethality discovery [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Expanding and Translating Cancer Synthetic Vulnerabilities; 2024 Jun 10-13; Montreal, Quebec, Canada. Philadelphia (PA): AACR; Mol Cancer Ther 2024;23(6 Suppl):Abstract nr B014.

A pilot randomized controlled study to determine the effectiveness of video educational tool in BRCA1/2 pre‐test counseling for Japanese breast cancer patients

AbstractBRCA1/2 genetic testing has become clinically important in breast cancer care, but increasing demand may put a burden on the shortage of healthcare professionals. We performed a single‐center, pilot randomized controlled study to assess the effectiveness of employing a video educational tool that included standard pre‐test genetic counseling elements related to BRCA1/2. Patients with operable breast cancer who met the criteria for genetic testing based on age, sex, subtype, and family history were recruited. Sixty consenting participants were randomized 1:1 and placed in groups that received either traditional face‐to‐face pre‐test counseling or video‐viewing and face‐to‐face decisional support. To assess decisional conflict in the participants, surveys based on the Decisional Conflict Scale (DCS) were administered two times, once immediately after intervention and again 2–4 weeks later. The time taken for counseling and confirmation of whether the participants had undergone testing were also recorded. The difference in the total DCS scores between the two groups was not significantly different for either of the survey periods, and there was no significant difference in the number of participants who underwent testing (23/30 [76.7%] vs. 26/30 [86.7%]; p = 0.51). However, the “effective decision” subscale score was significantly higher in the video group 2–4 weeks after counseling (31.01 ± 16.82 vs. 21.43 ± 16.09; p = 0.04 [mean ± SD]). The time taken for counseling was significantly shorter in the video group (8.00 ± 4.5 vs. 27.00 ± 7.61 min; p < 0.001 [median ± SD]). Our findings indicate the potential benefit of the video educational tool for providing BRCA1/2‐related information. These tools may also enable healthcare professionals to spend more time supporting psychological issues. Notably, after some time, patients may question whether their decision was appropriate. Therefore, it is necessary to identify those in conflict and provide them with proper support.